DocumentVersion

: Public Class

Created:	5/21/2010 11:52:16 AM
Modified:	1/27/2015 1:16:44 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{D6A7CEBA-70F4-44cf-AC7B-7D4177D6001F}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View SA: Statistical Analysis, View AE: Adverse Event, View CM: Common, BRIDG BackBone, View PR: Protocol Representation, Study Versioning View, View RG: Regulatory, View SC: Study Conduct

DEFINITION: A representation of a particular edition or snapshot of a document as it exists at a particular point in time. EXAMPLE(S): Version 3 of a case report form (CRF) for a physical exam, version 2 of an informed consent form. OTHER NAME(S): NOTE(S):

Attributes
Associations To
Associations From
Tagged Values
Constraints
Other Links

Attribute

Public ST.SIMPLE
numberText

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:AE=SafetyReport.initialReportIndicator
Map:C3PR=Study.consentVersion
Map:C3PR=StudySubject.informedConsentVersion
Map:C3PRv2.9=StudyVersion.name
Map:caAERSv2.2=ReportVersion.reportVersionId
Map:CTOM=Protocol.amendmentIdentifier
Map:CTR&Rr2=Sponsor protocol version
Map:CTRPv1.0=InterventionalStudyProtocol.revision
Map:CTRPv1.0=ObservationalStudyProtocol.revision
Map:CTRPv1.0=Document.revision
Map:CTRPv1.0=StudyProtocol.revision
Map:CTRPv3.8=StudyProtocol.amendmentNumberText
Map:CTRRr3=Document.revisionNumberText
Map:CTRv1.0=DocumentVersion.numberText
Map:FDA HL7 SD SD DSTU2012=relatedDocument.versionNumber
Map:FDA HL7 SD SD DSTU2012=StudyProtocol.versionNumber
Map:HL7SD=PlannedStudy.versionNumber
Map:LSDAM=DocumentVersion.versionNumberText
Map:NCI CRF Standard=CDE 3008888v1.0: Case Report Form Version Number
Map:PSCv2.6=Amendment.name
Map:RPS1=Documentation.version
Map:Statistics v1.0=DocumentVersion.numberText

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A character string that identifies a given document version.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;In RPS this could be implemented as follows: The version number would be an integer starting at '1' and incrementing by 1. The first instance or original report should always be valued as '1'. The version number value must be incremented by one when a report is replaced, but can also be incremented more often to meet local requirements. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Different versions of the same document belong to the same document group.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Over time, there may be multiple changes to a document, and the version allows an individual to capture relationships between changes in the instances of a document over time. There can be a new version every time the content changes. #lt;br /#gt;#lt;/p#gt;

Public ST
officialTitle

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:C3PR=Study.longTitleText
Map:C3PRv2.9=Consent.name
Map:C3PRv2.9=StudyVersion.longTitleText
Map:caAERSv2.2=Study.longTitleText
Map:CTGOV=Official Title
Map:CTOM=Protocol.longTitleText
Map:CTR&Rr2=Full title of the trial
Map:CTRPv1.0=ObservationalStudyProtocol.officialTitle
Map:CTRPv1.0=InterventionalStudyProtocol.officialTitle
Map:CTRPv3.8=StudyProtocol.officialTitle
Map:CTRRr3=Document.officialTitle
Map:CTRv1.0=DocumentVersion.officialTitle
Map:HCTv1.0=CDE 2978255:Research Protocols.Specify the research activity the recipient participates in:
Map:HL7SD=PlannedStudy.title
Map:HSDBv1.0=[Study].Study Title
Map:ICSRr2=document.title (in IndividualCaseSafetyReport)
Map:ICSRr2=ResearchStudy.title (in IndividualCaseSafetyReport)
Map:ICSRr2=RelatedInvestigation.title (in IndividualCaseSafetyReport)
Map:Lab=Study.name
Map:LabViewer2.2=Study.name
Map:LSDAM=DocumentVersion.officialTitle
Map:NCI CRF Standard=CDE 3009034v1.0: Case Report Form Name
Map:PSC=Study.name
Map:RPS1=Documentation.title
Map:Statistics v1.0=DocumentVersion.officialTitle
Map:WHO=Scientific Title

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The formal title of the document version. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;If there is only one title, use this attribute.#lt;br /#gt;#lt;/p#gt;

Public CD
languageCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRv1.0=DocumentVersion.languageCode
Map:FDA HL7 SD SD DSTU2012=StudyProtocol.languageCode
Map:Statistics v1.0=DocumentVersion.language

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the language that the document is written in.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;English, German#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;This attribute is used to indicate the language in which all (or most) of the discrete data elements that make up the document are expressed. This is distinct from the DocumentVersion.text(ED).languageCode property which expresses the language in which the document is rendered. This attribute is most important in circumstances where the document is not rendered.#lt;br /#gt;#lt;/p#gt;

Public TS.DATETIME
date

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:caAERSv2.2=ReportVersion.createdOn
Map:caAERSv2.2=Report.createdOn
Map:CTR&Rr2=Sponsor protocol version date
Map:CTRPv3.8=StudyProtocol.amendmentDate
Map:CTRR=Sponsor Protocol Version Date
Map:CTRRr3=Document.versionDate
Map:CTRv1.0=DocumentVersion.date
Map:HCTv1.0=CDE 2768219:Medical Records and Forms.What is the post transplantation time period for this follow up report?
Map:ICSRr2=RelatedInvestigation.availabilityTime (in IndividualCaseSafetyReport)
Map:ICSRr2=InvestigativeEvent.availabilityTime (in IndividualCaseSafetyReport)
Map:LabViewer2.2=Study.amendmentDate
Map:LSDAM=DocumentVersion.versionDate
Map:NCI CRF Standard=CDE 3008890v1.0: Case Report Form Version Date
Map:PSCv2.6=Amendment.date
Map:Statistics v1.0=DocumentVersion.date

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The date (and time) on which the document is versioned.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;

Public DSET<CD>
keywordCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to *
Transient:	False
Derived:	False
IsID:	False

AE:Exclude=True
Map:CTGOV=Keywords
Map:CTRPv1.0=InterventionalStudyProtocol.keywordCode
Map:CTRPv1.0=StudyProtocol.keywordCode
Map:CTRPv1.0=ObservationalStudyProtocol.keywordCode
Map:CTRR=Keywords
Map:CTRv1.0=DocumentVersion.keywordCode
Map:LSDAM=DocumentVersion.keywordCode
Map:RPS1=Keyword.code
Map:Statistics v1.0=DocumentVersion.keywordCode
Map:WHO=Keyword

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying a word or phrase that describes the document version and/or its context. Keywords help users find documents of interest. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;species, indication, biocompatibility, drug substance, drug product#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;

Public DSET<ST>
keywordText

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to *
Transient:	False
Derived:	False
IsID:	False

AE:Exclude=True
Map:CTGOV=Keywords
Map:CTRPv1.0=StudyProtocol.keywordText
Map:CTRPv1.0=ObservationalStudyProtocol.keywordText
Map:CTRPv1.0=InterventionalStudyProtocol.keywordText
Map:CTRPv3.8=StudyProtocol.keywordText
Map:CTRR=Keywords
Map:CTRRr3=Document.keywordText
Map:CTRv1.0=DocumentVersion.keywordText
Map:LSDAM=DocumentVersion.keywordText
Map:RPS1=Keyword.textValue
Map:Statistics v1.0=DocumentVersion.keywordText

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A character string of a word or phrase that describes the document version and/or its context. Keywords help users find documents of interest.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;species, indication, biocompatibility, drug substance, drug product#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;

Public TEL.URL
uniformResourceLocator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	True
IsID:	False

Map:AE=Document.universalResourceLocator
Map:CTOM=Protocol.documentUri
Map:CTRPv1.0=Document.universalResourceLocator
Map:CTRPv3.8=Document.fileName
Map:CTRPv3.8=Document.universalResourceLocator
Map:CTRv1.0=DocumentVersion.uniformResourceLocator
Map:PGx v1.0=PF.PFXFN
Map:PGx v1.0=PG.PGXFN
Map:RPS1=Documentation.fileID
Map:Statistics v1.0=DocumentVersion.uniformResourceLocator

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A complete or local reference to a website, ftp, file path or other location from which the document version contents can be retrieved.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived from DocumentVersion.text.ED.reference.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Local references should only be used when communicating between systems capable of resolving the local reference.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;In a Regulatory Product Submission (RPS) message, this identifies the file (with a Uniform Resource Identifier (URI)), which is part of the documentation. A URI is a compact string of characters used to identify or name a resource. The main purpose of this identification is to enable interaction with representations of the resource over a network, typically the World Wide Web, using specific protocols. URIs are defined in schemes defining a specific syntax and associated protocols.#lt;br /#gt;#lt;/p#gt;

Public ED
bibliographicDesignation

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRPv1.0=InterventionalStudyProtocol.bibliographicDesignation
Map:CTRPv1.0=StudyProtocol.bibliographicDesignation
Map:CTRPv1.0=ObservationalStudyProtocol.bibliographicDesignation
Map:CTRPv3.8=StudyProtocol.bibliographicDesignation
Map:CTRv1.0=DocumentVersion.bibliographicDesignation
Map:ICSRr2=document.bibliographicDesignationText (in IndividualCaseSafetyReport)
Map:LSDAM=DocumentVersion.bibliographicDesignation
Map:Statistics v1.0=DocumentVersion.bibliographicDesignation

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A text block containing publishing and authoring information that allows receivers of this document version to refer appropriately to this document version.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Good Health Hospital IRB Minutes, 18-Jan-2008#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;

Public DSET<CD>
revisionReasonCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to *
Transient:	False
Derived:	False
IsID:	False

Map:C3PRv2.9=StudyVersion.AmendmentReason
Map:CTRPv3.8=StudyProtocol.amendmentReasonCode
Map:CTRPv3.8=Document.inactiveCommentText
Map:CTRv1.0=DocumentVersion.revisionReason
Map:HL7SD=PlannedStudy.reasonCode
Map:HL7SDr1=ControlActEvent.reasonCode
Map:ICSRr2=ControlActEvent.reasonCode (in IndividualCaseSafetyReport)
Map:LSDAM=DocumentVersion.revisionReason
Map:Statistics v1.0=DocumentVersion.revisionReasonCode

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying why the previous version of the document was revised to this version.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;

Public CD
confidentialityCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRv1.0=DocumentVersion.confidentialityCode
Map:FDA HL7 SD SD DSTU2012=StudyProtocol.confidentialityCode
Map:ICSRr2=ControlActEvent.confidentialityCode (in IndividualCaseSafetyReport)

Notes:

DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the degree of sensitivity associated with the document.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Normal, Restricted, Very Restricted#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;

Element	Source Role	Target Role
«Comment_Requested» Protocol Class	Name: containingDocumentVersion	Name: containedProtocol
Details: DESCRIPTION:<br /></p><p>Each DocumentVersion might contain one Protocol. Each Protocol might be the contents of one DocumentVersion.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
«Comment_Requested» PerformedObservationResult Class	Name: containingDocumentVersion	Name: containedPerformedObservationResult
Details: DESCRIPTION:<br /></p><p>Each DocumentVersion might contain one or more PerformedObservationResult. Each PerformedObservationResult might be the contents for one or more DocumentVersion.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>A finding might be published in a scientific journal.<br /></p><p><br /></p><p>A data set produced by a computational process might be circulated as a document.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
Document Class	Name: versioningDocumentVersion	Name: versionedDocument
Details: DESCRIPTION:<br /></p><p>Each DocumentVersion always is a version of one Document. Each Document might have as a version one or more DocumentVersion.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>

Element	Source Role	Target Role
DocumentVersionRelationship Class	Name: sourceDocumentVersionRelationship	Name: targetDocumentVersion
Details: DESCRIPTION:<br /></p><p>Each DocumentVersionRelationship always has as target one DocumentVersion. Each DocumentVersion might be the target for one or more DocumentVersionRelationship.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
PerformedSubjectMilestone Class	Name: usingPerformedStudySubjectMilestone	Name: usedDocumentVersion
Details: DESCRIPTION:<br /></p><p>Each PerformedSubjectMilestone might use one DocumentVersion. Each DocumentVersion might be used for one or more PerformedSubjectMilestone.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
DocumentVersionRepresentation Class	Name: representingDocumentVersionRepresentation	Name: representedDocumentVersion
Details: DESCRIPTION:<br /></p><p>Each DocumentVersionRepresentation always represents one DocumentVersion. Each DocumentVersion always is represented as one or more DocumentVersionRepresentation. <br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
DocumentVersionRelationship Class	Name: targetDocumentVersionRelationship	Name: sourceDocumentVersion
Details: DESCRIPTION:<br /></p><p>Each DocumentVersionRelationship always has as source one DocumentVersion. Each DocumentVersion might be the source for one or more DocumentVersionRelationship.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
DocumentVersionWorkflowStatus Class	Name: describingDocumentVersionWorkflowStatus	Name: describedDocumentVersion
Details: DESCRIPTION:<br /></p><p>Each DocumentVersionWorkflowStatus always describes one DocumentVersion. Each DocumentVersion might be described by one or more DocumentVersionWorkflowStatus.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
DefinedNotification Class	Name: attachingDefinedNotification	Name: attachedDocumentVersion
Details: DESCRIPTION:<br /></p><p>Each DefinedNotification might have as an attachment one or more DocumentVersion. Each DocumentVersion might be an attachment on one or more DefinedNotification.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
SubmissionUnit Class	Name: includingSubmissionUnit	Name: includedDocumentVersion
Details: DESCRIPTION:<br /></p><p>Each SubmissionUnit always includes one or more DocumentVersion. Each DocumentVersion might be included in one or more SubmissionUnit.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
DefinedStudySubjectMilestone Class	Name: usingDefinedStudySubjectMilestone	Name: usedDocumentVersion
Details: DESCRIPTION:<br /></p><p>Each DefinedStudySubjectMilestone might use one DocumentVersion. Each DocumentVersion might be used for one DefinedStudySubjectMilestone.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
DocumentAuthor Class	Name: authoringDocumentAuthor	Name: authoredDocumentVersion
Details: DESCRIPTION:<br /></p><p>Each DocumentAuthor always authors one DocumentVersion. Each DocumentVersion always is authored by one or more DocumentAuthor.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>

Tag	Value
Map:C3PRv2.9	Consent
Details:
Map:C3PRv2.9	StudySubjectConsentVersion
Details:
Map:caAERSv2.2	NotificationAttachment
Details:
Map:CTRRr3	Document
Details:
Map:CTRv1.0	DocumentVersion
Details:
Map:LSDAM	DocumentVersion
Details:
Map:LSDAMv2.2.3Plus	DocumentVersion
Details:
Map:Statistics v1.0	DocumentVersion
Details:

Constraint	Type	Status
language Qualifier	Invariant	Approved
Details: DocumentVersion.languageCode must equal DocumentVersion.text(ED).languageCode if both are non-null.

Object	Type	Connection	Direction	Notes
StudySubjectExperienceDocumentVersion	Class	Generalization	From	DESCRIPTION: Each StudySubjectExperienceDocumentVersion always specializes one DocumentVersion. Each DocumentVersion might be specialized by one StudySubjectExperienceDocumentVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
StudyProtocolDocumentVersion	Class	Generalization	From	DESCRIPTION: Each StudyProtocolDocumentVersion always specializes one DocumentVersion. Each DocumentVersion might be specialized by one StudyProtocolDocumentVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
AmendmentChangeSummaryVersion	Class	Generalization	From	DESCRIPTION: Each AmendmentChangeSummaryVersion always specializes one DocumentVersion. Each DocumentVersion might be specialized by one AmendmentChangeSummaryVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
ReportVersion	Class	Generalization	From	DESCRIPTION: Each ReportVersion always specializes one DocumentVersion. Each DocumentVersion might be specialized by one ReportVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
StatisticalAnalysisPlanDocumentVersion	Class	Generalization	From	DESCRIPTION: Each StatisticalAnalysisPlanDocumentVersion always specializes one DocumentVersion. Each DocumentVersion might be specialized by one StatisticalAnalysisPlanDocumentVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):
DataMonitoringCommitteeCharterVersion	Class	Generalization	From	DESCRIPTION: Each DataMonitoringCommitteeCharterVersion always specializes one DocumentVersion. Each DocumentVersion might be specialized by one DataMonitoringCommitteeCharterVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):